Apparatus and methods for treating sleep apnea

ABSTRACT

Apparatus and methods are provided for treating sleep apnea, snoring, and the like using an implant within an oropharyngeal region adjacent an anterior longitudinal ligament. The implant may include a relatively narrow central region between first and second relatively wide outer regions. In one embodiment, one of the outer regions is compressible to allow the outer region to be directed through or behind the ligament such that the central region is disposed within or behind the ligament, the outer region being resiliently expandable after passing through or behind the ligament. In another embodiment, the implant may include one or more tines or other features that may be directed into adjacent tissue to secure the implant within the oropharyngeal region.

RELATED APPLICATION DATA

This application claims benefit of co-pending provisional applicationsSer. No. 61/422,578, filed Dec. 13, 2010, No. 61/521,662, filed Aug. 9,2011, and No. 61/541,974, filed Sep. 30, 2011. The entire disclosures ofthese applications are expressly incorporated by reference herein.

FIELD OF THE INVENTION

The present invention generally relates to apparatus and methods fortreating sleep apnea, snoring, and/or other breathing disorders, andmore specifically relates to apparatus for placement in theoropharyngeal region of a human or animal and to methods for treatingsleep apnea, snoring, and/or other breathing disorders.

BACKGROUND

Sleep apnea is a sleep-related breathing disorder that is thought toaffect between one and ten percent (1-10%) of the adult population.Recent epidemiologic data indicate that two percent (2%) of women andfour percent (4%) of men between the ages of thirty (30) and sixty (60)years old meet the minimum diagnostic criteria for sleep apnea syndrome,representing more than ten million individuals in the United States. Itis a disorder with significant morbidity and mortality, contributing toincreased risk of hypertension, cardiac arrhythmias, stroke, andcardiovascular death. Another common sleep-related breathing disorder issnoring, which may be associated with or independent of sleep apnea.

One of the main reasons for sleep disturbance is relaxation of thetongue and pharyngeal walls to varying degrees during the several stagesof sleep. When fully awake, these tissues have normal tone as air passesin and out of the lungs during respiration. However, during sleep, themusculature supporting these tissues relaxes. As air is inspired, thetongue and walls of the pharynx collapse, causing snoring or moreseriously, causing partial or complete obstruction of the airway.

Obstructive sleep apnea occurs due to a collapse of soft tissue withinthe upper airway during sleep. The ongoing force of inspiration servesto generate increasingly negative pressure within the pharynx, causingfurther collapse. The lack of respiration results in inadequate bloodoxygenation, and rising carbon dioxide levels. The cardiovascularresponse produces an increase in blood pressure and pulse. Cardiacarrhythmias often occur. The carbon dioxide increase and oxygendesaturation triggers a transition to a lighter sleep stage, usuallywithout wakefulness. This transition brings a return to tonicity of themuscles of the upper airway, allowing normal breathing to resume. Theperson then returns to deeper stages of sleep and the process isrepeated. The disease is quantified in terms of respiratory disturbancesper hour. Mild disease begins at ten per hour, and it is not uncommon tofind patients with indices of about one hundred or more.

Not surprisingly, sleep is extremely fragmented and of poor quality inpersons suffering from sleep apnea. As a result, such persons typicallyfeel tired upon wakening and may fall asleep at inappropriate timesduring the day. All aspects of quality of life, from physical andemotional health, to social functioning are impaired by obstructivesleep apnea.

Continuous Positive Airway Pressure (“CPAP”) is a popular non-surgicaltreatment for patients suffering from sleep apnea. CPAP is administeredby means of a mechanical unit that delivers pressurized room air to thenasal passage, or airway, through a nose mask that is worn by thepatient during sleep. Pressurized air enters from the CPAP unit throughthe nose when a person is sleeping, and opens the airway from the insidealmost as if the air were an internal splint. The correct pressure forthe individual is determined in a sleep laboratory. If the nasal airwayadmits the flow of air, CPAP has in many cases offered immediate relief.Unfortunately however, compliance with, and long-term acceptance of thistreatment are generally poor. Studies have shown that between twenty andfifty percent (20-50%) of patients fail to use nasal CPAP as prescribed.Problems associated with CPAP include excessive dryness of the mouth andthroat, mucous congestion, sinusitis, and rhinorrhea. Breathing againstpositive air pressure is also discomforting to many patients.

Other non-surgical treatments for sleep apnea include the use of tongueretaining devices and other oral appliances that hold and/or pull thetongue or jaw in a forward position to open the airway by reducingcollapse of the soft palate and/or tongue. These devices also sufferfrom poor compliance rates, and are usually associated with degenerativechanges in the temporomandibular joint.

Surgical procedures have also been proposed and/or practiced for thetreatment of moderate to severe sleep apnea. Uvulopalatopharyngoplasty(“UPPP”) is a surgical procedure used to treat obstructive sleep apnea.In UPPP, any remaining tonsillar tissue and a portion of the soft palateis removed. The procedure increases the width of the airway at thethroat opening. However, UPPP does not address apnea caused byobstructions deeper in the throat and airway, for example, apnearesulting from collapse of tissue near the base of tongue or in theoropharyngeal region of the airway.

LAUP, or Laser-Assisted Uvulopalatoplasty, is a modification of theabove-mentioned technique, but has not proven particularly useful forsleep apnea. These surgical techniques are extremely invasive, requiringgeneral anesthesia, and a prolonged, painful recovery.

Radio frequency tissue ablation (“RFTA”) has also been suggested forshrinking the soft palate, uvula and reduce tongue volume in thetreatment of snoring and obstructive sleep apnea. Somnoplasty utilizes aradiofrequency tool that generates heat to create coagulative lesions atspecific locations within the upper airway. The lesions created by theprocedure are naturally resorbed in approximately three to eight weeks,reducing excess tissue volume and increasing the airway opening. LikeUPPP and LAUP, more than one session is typically required and it doesnot address sleep apnea resulting from tissues deeper in the throat thanthe upper airway.

Another area of surgical interest lies in techniques designed to pullthe tongue anteriorly. For example, a tongue suspension procedure hasbeen suggested in which the tongue is pulled forward, thereby keepingthe tongue from falling into the airway during sleep. The systemutilizes a bone screw inserted into the mandible. The screw attaches toa non-absorbable suture which travels the length of the tongue and back.Similarly, the hyoid bone can be drawn anteriorly with two distinctscrews, also attached to the mandible.

Techniques have also been developed for treating, specifically, thecondition of snoring. For example, U.S. Pat. No. 6,250,307 to Conrad etal. discloses a method for treating snoring of a patient that includesembedding a fibrosis-inducing implant into a soft palate of a patient inorder to alter a dynamic response of a soft palate to airflow.

Concepts relating to implants in the pharyngeal area have been describedin German publication DE 19,920,114 to Fege, published Nov. 9, 2000,which discloses transverse implant bands attached at one end to thecervical vertebra via surgical slits through the tongue, tonsils, andpharyngeal tissue. Other pharyngeal implants have been described in U.S.Publication No. 2003/0149488 to Metzger et al., now U.S. Pat. No.7,017,582.

These conventional devices and treatments continue to suffer poor curerates. The failures may lie in their inability to maintain patency inthe retropalatal region and retroglossal region (the caudal margin ofthe soft palate to the base of the epiglottis). The poor success ratescombined with high morbidity, contribute to an ongoing need for moreeffective treatments for sleep apnea and/or snoring.

SUMMARY

The present invention is directed to apparatus and methods for treatinghuman subjects, for example, to substantially eliminate or at leastreduce the occurrence of sleep apnea, snoring, and/or othersleep-related breathing disorders. The apparatus and methods may berelatively straightforward in structure and use, may be minimallyinvasive, and/or may provide substantial benefits over conventionaltechniques in controlling sleep apnea and/or snoring.

In accordance with one embodiment, an apparatus is provided forimplantation within an oropharyngeal region adjacent a ligament thatincludes an implant including a relatively narrow central region betweenfirst and second relatively wide outer or end regions. The outer regionsmay be foldable, rollable, compressible, or otherwise displaced out ofplane towards one another such that the implant defines a generally “C”shape about a vertical axis. In addition, the outer regions may bebiased to open away from the vertical axis such that the first andsecond regions apply a force to dilate tissue adjacent the oropharyngealregion when the implant is disposed within the oropharyngeal region.

At least one of the outer regions may be compressible vertically toallow the at least one of the outer regions to be directed through orbehind the ligament adjacent the oropharyngeal region such that thecentral region is disposed within or behind the ligament. The outerregion(s) may be resiliently expandable after passing through or behindthe ligament to return towards their original relatively wideconfiguration. Optionally, the outer regions may define an open area oneither side of the central region, e.g., including mesh, struts, orother features, if desired.

Optionally, a sleeve may surround at least a portion of the centralregion. In addition or alternatively, one or more features may beprovided on the central region, e.g., one or more tines, pins, and thelike, for engaging tissue adjacent an oropharyngeal region. In someembodiments, the central region may be a separate component that isplaced initially in vivo to which the outer region may be assembledsecondarily in situ. The assembly of the outer region to the centralregion may be accomplished using various connectors, fasteners, and/ormethods, e.g., by mechanical, chemical, suturing, or magnetic means.

In accordance with another embodiment, an apparatus is provided forimplantation within an oropharyngeal region adjacent a ligament thatincludes an implant including a central region between first and secondends, and one or more features or elements on the central region forengaging tissue to secure the implant within the oropharyngeal region.In one embodiment, the implant may have an oval or oblong shape definingan open area surrounded by a periphery, and may include a major axisbetween the first and second ends and a minor axis extending across thecentral region. In another embodiment, the implant may include arelatively narrow central region between first and second relativelywide outer regions adjacent the first and second ends. Optionally, oneor more struts may extend across the open area, e.g., across the centralregion and/or across outer regions adjacent the first and second ends.

The one or more features may include sets of tines, for example,opposite one another on the periphery of the implant, e.g., across thecentral region. For example, the tines may be substantially rigid and/ormay extend substantially perpendicular to the plane of the implant.Alternatively, the tines may be biased to extend transversely, e.g.,diagonally relative to the plane of the implant. For example, the tinesmay be biased to extend away from one another or may extend towards oneanother, e.g., such that their ends at least partially cross oneanother, yet may be resiliently directed to a substantiallyperpendicular orientation to facilitate insertion into tissue. In anexemplary embodiment, the tines may be biased to a curved configurationyet may be resiliently directly to a substantially straightconfiguration to facilitate insertion into tissue.

In accordance with yet another embodiment, an apparatus is provided forimplantation within an oropharyngeal region adjacent a ligament thatincludes an implant including a plurality of implant components that areconnectable together to define a relatively narrow central regionbetween first and second relatively wide outer regions, e.g., definingan open area on either side of the central region. In one embodiment, apair of implant components may be provided that are connectable at thecentral region such that each implant component includes one of theouter regions. For example, the central region of a first implantcomponent may be configured to be introduced through or behind ananterior longitudinal ligament, and the central region of a secondimplant component may be connectable to the first implant component suchthat the outer regions are disposed on either side of the ligament.

In accordance with another embodiment, the central region of the implantmay be attached to the ligament through the use of anchoring screws,coils, or other attachments. These anchoring coils may be manuallyscrewed into the tissue securing the central region of the implant tothe ligament or they may thread into the tissue automatically. Similarto a wound spring, these coils may unwind and be forced to thread intotissue upon release. These coils may be separate components or integralto the central region. The coils may be configured to attach the centralregion or the entire implant, e.g., central and outer regions combined,in one step. In addition, the coils may be attached to portions of theouter regions of the implant if desired.

In accordance with still another embodiment, an implant is provided thatincludes a relatively narrow central region between first and secondrelatively wide outer regions, e.g., each defining a substantiallyenclosed open area. The outer regions are compressible vertically toallow them to be directed through or behind the ligament adjacent theoropharyngeal region such that the central region is disposed within orbehind the ligament. Optionally, the central region may include a sleeveat least partially surrounding the central region and/or one or morefeatures for engaging tissue adjacent the implant, e.g., for securingthe implant relative to the tissue.

In accordance with another embodiment, an implant is provided thatincludes an enclosed loop structure including a relative narrow centralregion between relative wide first and second regions. The first andsecond regions may be rollable, foldable, compressible, or otherwisedisplaced out of plane towards one another such that the implant definesa generally “C” shape about a vertical axis, the first and secondregions being biased to open away from the vertical axis, e.g., to asubstantially planar configuration, when unconstrained such that thefirst and second regions apply a force to dilate tissue adjacent theoropharyngeal region when the implant is disposed within theoropharyngeal region. Optionally, at least one of the first and secondregions may be compressible vertically to allow the at least one of thefirst and second regions to be directed through or behind the ligamentadjacent the oropharyngeal region such that the central region isdisposed within or behind the ligament, the at least one of the firstand second regions being resiliently expandable after passing through orbehind the ligament.

In accordance with still another embodiment, a system is provided fortreating sleep apnea, snoring, and/or other breathing disorders thatincludes an implant including a relatively narrow central region betweenrelatively wide first and second regions, and a needle coupled to thefirst end region by a filament for insertion through tissue and/or aligament adjacent an oropharyngeal region. At least the first region maybe compressible vertically to allow the first region to be directedthrough or behind the ligament the needle and filament are insertedthrough or behind the ligament such that the central region is disposedwithin or behind the ligament, the first region being resilientlyexpandable after passing through or behind the ligament. The first andsecond regions may also foldable, rollable, compressible or otherwisedisplaceable towards one another such that the implant defines agenerally “C” shape about a vertical axis. The first and second regionsmay be biased to open away from the vertical axis within the horizontalplane when unconstrained such that the first and second regions apply aforce to dilate tissue adjacent the oropharyngeal region when theimplant is disposed within the oropharyngeal region. The first andsecond regions may increase a surface area contacting adjacent tissue,which may facilitate dilating, opening, or otherwise treating tissueadjacent the oropharyngeal region. Other automated tools may be used topass a needle and filament through or behind the ligament. Such toolsmay control the depth, penetration force, and/or width of the needlepass through or behind the ligament.

The implants, apparatus, and/or systems herein may include any materialor materials suitable for placement in the pharyngeal region that may beeffective to reinforce tissues of the region in order to provide supportto these tissues against collapse such that a patient can breathe moreeffectively than the patient would breathe without the material ormaterials placed in the region. For example, the implants may be formedfrom pre-shaped wire that may be biased to a predetermined shape butelastically deformable to facilitate introduction and/or implantationwithin a patient's body. Alternatively, the implants may be formed froma sheet, e.g., by laser-cutting, machining, etching, or otherwiseremoving undesired regions of the sheet to create the desired implant.In an exemplary embodiment, the implant may be formed from elasticmaterial, such as a super-elastic material, e.g., Nitinol, or othermetals, such as stainless steel, elgiloy, titanium, polymers, orcomposite materials.

Tissue engagement may be enhanced by making the implant securingfeatures porous for tissue in-growth or made from a biocompatiblematerial that elicits tissue in-growth such as materials made withpolyester or porous ceramic, spring steel, and the like. Alternatively,the surface of the implant may be coated with one or more pharmaceuticalor biological agents, e.g., to promote or retard reactions by thesurrounding tissue and blood circulation such as: tissue in-growth,tissue encapsulation, reduction of tissue proliferation, enhancedmucosalization, and/or other potentially beneficial effects.

In accordance with another embodiment, a method is provided for treatingsleep apnea or snoring within an oropharyngeal region adjacent ananterior longitudinal ligament that includes introducing an implant intothe oropharyngeal region, the implant comprising a relatively narrowcentral region between relatively wide first and second regions. Thefirst region may be introduced through an opening through or behind theligament, while compressed vertically from a relaxed configuration asthe first region passes through the opening. After the first regionpasses through the opening, the first region may resiliently expandtowards the relaxed configuration, the central region remaining withinthe opening.

In accordance with yet another embodiment, an apparatus is provided forimplantation within an oropharyngeal region that includes an implantincluding a central region between first and second outer regionsgenerally defining a plane in a substantially flat configuration. Theouter regions may define lobes surrounding respective open interiorspaces on either side of the central region. The outer regions may bedisplaceable out of the plane such that the implant defines a curvedconfiguration; and a first pair of opposing tines may be provided on theimplant including tips oriented towards one another adjacent the centralregion in the substantially flat configuration, the tips being directedaway from one another when the implant is directed to the curvedconfiguration to define a space therebetween for receiving tissue whenthe implant is introduced into an oropharyngeal region. The outerregions may be biased towards the substantially flat configuration toapply a force to dilate tissue adjacent the oropharyngeal region whenthe implant is disposed within the oropharyngeal region and to directthe tines towards one another to engage tissue received within the spacebetween the tips.

In accordance with still another embodiment, an apparatus is providedfor implantation within an oropharyngeal region adjacent a ligament thatincludes an implant including a central region between first and secondouter regions, the outer regions defining lobes and defining asubstantially flat configuration in a relaxed state lying generallywithin a plane, the outer regions biased towards the substantially flatconfiguration to apply a force to dilate tissue adjacent theoropharyngeal region when the implant is disposed within theoropharyngeal region; and one or more pairs of tines extendingtransversely from the central region out of the plane in the relaxedstate to define a transverse orientation, the tines resilientlydirectable to a delivery orientation wherein tips of the tines extendsubstantially perpendicular to the plane, the tines biased to returntowards the transverse orientation.

In accordance with another embodiment, a system is provided for treatingat least one of sleep apnea and snoring that includes an implant and atool. The implant may include a central region between first and secondouter regions, the outer regions defining lobes and defining asubstantially flat configuration lying generally within a plane, theouter regions biased towards the substantially flat configuration toapply a force to dilate tissue adjacent the oropharyngeal region whenthe implant is disposed within the oropharyngeal region; and one or morepairs of tines extending transversely from the central region out of theplane to define a transverse orientation. The tool may include anelongate shaft including a proximal end and a distal end sized forintroduction into an oropharyngeal region, and one or more features onthe tool distal end for slidably engaging the tines to direct the tinesto a delivery orientation wherein tips of the tines extend substantiallyperpendicular to the plane when the implant is loaded onto the tooldistal end. The tool may also include a delivery member for deployingthe implant from the tool distal end, the tines biased to return towardsthe transverse orientation when the implant is deployed from the tooldistal end.

In accordance with still another embodiment, a method is provided fortreating at least one of sleep apnea and snoring using an implantincluding a central region between first and second outer regions in arelaxed state, the implant comprising one or more pairs of tinesextending from the central region such that tips of the tines areoriented towards one another in the relaxed state. The implant may bedirected to a curved configuration wherein tips of the tines are spacedapart from one another, and introduced into an oropharyngeal region of apatient in the curved configuration. The tips of the tines may bedirected into tissue adjacent the posterior wall of the oropharyngealregion, and the implant may be released within the oropharyngeal regionsuch that the outer regions resiliently return towards the relaxed stateapply a force to against the lateral walls of the oropharyngeal regionand to direct the tines towards one another to engage tissue receivedwithin the space between the tips.

In accordance with yet another embodiment, a method is provided fortreating at least one of sleep apnea and snoring using an implantincluding a central region between first and second outer regions in arelaxed state, the implant comprising one or more pairs of tinesextending transversely from the central region in a transverseorientation in the relaxed state. The implant may be loaded onto adelivery tool such that the tines are directed to a delivery orientationwherein tips of the tines extend substantially perpendicular from thecentral region, and the implant may be introduced into an oropharyngealregion of a patient in the curved configuration. The implant may bedeployed from the tool such that the tips of the tines are directed intotissue adjacent the posterior wall of the oropharyngeal region, thetines resiliently returning towards the transverse orientation as theyenter the tissue.

Each and every feature described herein, and each and every combinationof two or more of such features, is included within the scope of thepresent invention provided that the features included in such acombination are not mutually inconsistent.

These and other aspects of the present invention are apparent in thefollowing detailed description and claims, particularly when consideredin conjunction with the accompanying drawings in which like parts bearlike reference numerals.

BRIEF DESCRIPTION OF THE DRAWINGS

The drawings illustrate exemplary embodiments, in which:

FIG. 1 is a cross-sectional view of a patient's head, showing anexemplary embodiment of an implant positioned in an oropharyngeal regionof the patient.

FIGS. 2A-2C are perspective, front, and top views, respectively, of anexemplary embodiment of an implant for treating sleep apnea, snoring,and/or other breathing disorders.

FIGS. 2D and 2E are front and top views of the implant of FIGS. 2A-2C,showing various dimensions.

FIG. 2F is detail of the implant of FIGS. 2A-2E.

FIGS. 3A and 3B are perspective and front views, respectively, ofanother exemplary embodiment of an implant for treating sleep apnea,snoring, and/or other breathing disorders.

FIGS. 4A and 4B are details of the oropharyngeal region of FIG. 1,showing an implant being advanced through or behind the anteriorlongitudinal ligament “ALL.”

FIG. 5. is a perspective view of yet another embodiment of an implantfor treating sleep apnea, snoring, and/or other breathing disorders thatincludes features for engaging the anterior longitudinal ligament orother tissue structures.

FIGS. 6A-6C are perspective, front, and top views, respectively, ofstill another embodiment of an implant for treating sleep apnea,snoring, and/or other breathing disorders.

FIGS. 7A-7C are perspective, front, and top views, respectively, of yetanother embodiment of an implant for treating sleep apnea, snoring,and/or other breathing disorders.

FIGS. 8A-8C are perspective, front, and top views, respectively, ofstill another embodiment of an implant for treating sleep apnea,snoring, and/or other breathing disorders.

FIG. 9 is a perspective view of still another embodiment of an implantfor treating sleep apnea, snoring, and/or other breathing disorders thatincludes features for engaging the anterior longitudinal ligament orother tissue structures.

FIG. 9A is a detail of an alternative embodiment of a tine that may beprovided on an implant, such as the implants of FIGS. 5 and 9.

FIGS. 10A-12C are front, top, and perspective views of anotherembodiment of an implant, showing the implant as formed from a flatsheet (FIGS. 10A-10C), in its relaxed state (FIGS. 11A-11C), and in acocked state to facilitate implantation (FIGS. 12A-12C).

FIG. 13A is a perspective view of a system including a tool fordelivering the implant of

FIGS. 10A-12C into an oropharyngeal region of a patient.

FIG. 13B and 13C are details of a distal end of the tool of FIG. 13A,showing the implant being directed to a curved configuration forintroduction into the oropharyngeal region of a patient.

FIGS. 14A and 14B are top views of an exemplary embodiment of an implantincluding a strut that may be used to anchor the implant relative to theposterior wall of an oropharyngeal region, e.g., by implanting thestruts through or behind the anterior longitudinal ligament or otherwisethrough tissue in the posterior wall.

FIGS. 15A-15D show alternative embodiments of implants that includestruts that may be used to anchor the implant relative to the posteriorwall of an oropharyngeal region.

FIG. 16 is a top view of yet another embodiment of an implant thatincludes struts for anchoring the implant relative to tissue, e.g., tothe posterior wall of an oropharyngeal region.

FIG. 17 is a front view of another embodiment of an implant for treatingsleep apnea, snoring, and/or other breathing disorders that is formedfrom separate support components that may be coupled together.

FIGS. 18A-18F show alternative embodiments of stents that may be passedat least partially through or behind the anterior longitudinal ligamentor otherwise through tissue to secure the stents within an oropharyngealregion.

FIGS. 19A-19C are top views of another embodiment of an implant, showingthe implant as formed from a flat sheet (FIG. 19A), in its relaxed state(FIG. 19B), and in a cocked state to facilitate implantation (FIG. 19C).

FIGS. 20A-20C are top views of still another embodiment of an implant,showing the implant as formed from a flat sheet (FIG. 20A), in itsrelaxed state (FIG. 20B), and in a cocked state to facilitateimplantation (FIG. 20C).

FIGS. 21A-21D are perspective, front, top, and side views, respectively,of yet another embodiment of an implant for treating sleep apnea,snoring, and/or other breathing disorders that includes tines forsecuring the implant to tissue biased to extend transversely relative toa plane of the implant.

FIGS. 22A-22D are perspective, front, top, and side views, respectively,of still another embodiment of an implant including tines for securingthe implant to tissue biased to extend transversely relative to a planeof the implant.

FIGS. 23A and 23B are perspective and side views of a tool in which theimplant of FIGS. 22A-22D has been loaded such that the tines extendsubstantially perpendicular to the plane of the implant.

FIGS. 24A and 24B are perspective and side views of the tool of FIGS.23A and 23B, showing a pusher member delivering the implant from thetool such that the tines are free to resiliently return to theirtransverse configuration.

FIGS. 25A and 25B are perspective and side views of the tool of FIGS.23A-24B, showing the implant released from the tool.

FIGS. 26A and 26B are perspective views of another embodiment of animplant for treating sleep apnea, snoring, and/or other breathingdisorders that includes apertures for receiving separate fasteners forsecuring the implant to tissue.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Generally, the apparatus and systems described herein include animplant, stent, or other appliance sized and/or structured to be placedin a given position in an oropharyngeal region of a human or animalpatient, e.g., for treating sleep apnea, snoring, and/or other breathingor sleeping disorders of the patient.

Turning now to the drawings, FIG. 1 shows a cross-sectional anatomicalview of a human patient or other subject 1. The patient 1 has anexemplary apparatus 10, which may be any of the embodiments describedherein, located within the patient's oropharyngeal region 1 a in orderto substantially control, reduce, eliminate, and/or otherwise treatsleep apnea, snoring, and/or other breathing disorders.

Snoring and sleep apnea are often caused by a combination of narrownessand low muscle tone of the upper airways. The tongue 2 a may fall backand obstruct the airway, possibly leading to an arousal reaction anddisturbing the normal sleeping pattern. Other portions of theoropharyngeal region may also collapse. For example, the lateral walls 2b of the oropharyngeal region often become excessively lax and block afree flow of air during respiration. When the patient 1 is supine, i.e.,when the patient 1 is asleep and lying on his/her back, the relaxedtongue 2 a may move inferiorly (down) and posteriorly (back), and/or thelateral walls 2 b of the oropharyngeal region may collapse inwardlyresulting in a narrower pharynx relative to when the patient 1 isupright. One cause for the narrowing of the pharynx in the supineposition may be that the oropharyngeal region 1 a and hypopharyngealregion, which have low consistencies, collapse because of lack of directhard tissue support.

The apparatus 10 may be secured to the oropharyngeal region by variousmethods. For example, the apparatus 10 may be elastically compressed toa smaller size to facilitate introduction, and released within theoropharyngeal region, whereupon the apparatus 10 may resiliently expandand thereby secure the apparatus 10 within the oropharyngeal region.Optionally, the apparatus 10 may be secured at least partially relativeto the longitudinal anterior ligament or within or through other tissues(not shown), e.g., using one or more tines or other features (not shown)on the apparatus 10 that may be delivered into or through tissueadjacent the oropharyngeal region, e.g., into the ligament and/or anadjacent vertebra, as described elsewhere herein. For example, a centralregion of the apparatus 10 may be placed through or behind the anteriorlongitudinal ligament, or the central region of the apparatus 10 mayinclude one or more features that engage the ligament, bone, or othertissue adjacent the poster wall of the oropharyngeal region 1 a.

Alternatively, the apparatus 10 may be sutured to the oropharyngealregion, e.g., with bioabsorbable sutures, which may allow the apparatus10 to be held in place while the apparatus 10 becomes fixed to theregion by means of tissue ingrowth. In a further alternative, separatefasteners, e.g., clips, staples, and the like (not shown), may be usedto secure the apparatus 10 to the oropharyngeal region. In addition oralternatively, the apparatus 10 may be secured to the region using abiocompatible adhesive. Alternatively still, the apparatus 10 may besecured to the region by being surgically implanted into the region,e.g., directly beneath the region's mucosal layer, for example, by beingpulled, with a surgical needle at least partially into and/or beneaththe mucosal layer such that the apparatus 10 at least partiallycircumscribes the region.

The apparatus 10 may be designed to provide direct support to at leastsome of these tissues when the patient 1 is supine and/or asleep. Forexample, the apparatus 10 may be structured so that when placed in adesired position in the oropharyngeal region 1 a, the apparatus 10 maypush the tongue forward, and/or push the lateral walls 2 b outwardlyaway from one another, thereby holding the airway patent or open duringthe time the patient 1 is naturally sleeping.

As shown, the apparatus 10 may be sized and structured to be positionedabove or adjacent the epiglottis 2 c of the patient 1, e.g., but withoutcoming in contact with the epiglottis 2 c. For example, in oneembodiment, the apparatus 10 is designed to overlay a posterior wall 2 dof the oropharyngeal region la and provide an opening force outwardlyagainst opposing lateral walls 2 b of the oropharyngeal region 1 a. Forexample, the apparatus 10 may be implanted within the oropharyngealregion 1 a above the epiglottis 2 c, e.g., laterally adjacent the C1-C4vertebrae, e.g., laterally adjacent or between the C2-C3 vertebrae (notshown). In other embodiments, the apparatus 10 may be designed to beplaced opposite or below the soft palate, or within a valecullar space 2e, and/or may provide a pushing force against the base 2 f of the tongue2 a, which makes up a portion of the anterior wall 2 g of theoropharyngeal region la. The valecullar space 2 e, as the term is usedherein, is defined as being the space between the anterior wall 2 g ofthe throat and the upper tip 2 h of the epiglottis 2 c down to theconjunction of the epiglottis 2 c with the anterior wall 2 g of thepharynx.

In any event, the apparatus 10 may be designed in such a manner as tosubstantially prevent the apparatus 10 from interfering substantiallywith the normal functioning of the tissue around the apparatus 10,particularly with the normal functioning of the epiglottis 2 c.

Optionally, the apparatus 10 may include features, structures, or otherelements (described elsewhere herein) for anchoring or securing theapparatus 10 within the oropharyngeal region 1 a, e.g., to prevent theapparatus 10 from migrating substantially away from or out of a givenposition in which the apparatus 10 is implanted. The apparatus 10 may bestructured to closely and flexibly conform to the size and contours ofat least a portion of the oropharyngeal region 1 a.

Turning to FIGS. 2A-2C, an exemplary embodiment of an apparatus 110 isshown that generally includes an implant, stent, or appliance 112 thatis foldable, rollable, compressible, or otherwise displaceable about avertical axis 116, and optionally a sleeve 114 extending along a centralportion 118 thereof. Optionally, the apparatus 110 may include otherfeatures, such as a needle 130 and/or suture 132, e.g., shown in FIGS.4A and 4B, or other delivery device (not shown), as described elsewhereherein.

From a front view, shown in FIG. 2B, the implant 112 has a generally“bow-tie” shape, i.e., including a relatively narrow central region 118flanked by relatively wide or broadened first and second outer regions120, “width” defined in a generally vertical direction, i.e., along thevertical axis 116. In addition, from a top view, shown in FIG. 2C, theimplant 112 has a curved shape in a direction perpendicular to thevertical axis 116. For example, as best seen in FIG. 2E, the centralregion 118 may curve generally around the vertical axis 116 to define afirst radius of curvature 140, while the first and second regions 120curve away from the vertical axis 116 to define a second radius ofcurvature 142. Thus, the implant 112 may define a generally “gull wing”shape when viewed from the top or bottom. Alternatively, the centralregion 118 and the outer regions 120 may both curve around the verticalaxis 116, e.g., in a substantially continuous “C” shaped curve, whichmay be a portion of a circle or ellipse (not shown), similar to implantsdisclosed in U.S. Publication No. 2008/0035158 and/or U.S. Pat. Nos.7,381,222 and 7,992,566, the entire disclosures of which areincorporated by reference herein. In further alternatives, the centralregion 118 and/or the outer regions 120 may be substantially planar,e.g., such that the entire implant 112 lies substantially within a plane(not shown).

As best seen in FIG. 2D, the outer regions 120 may include outer curvedsegments 144, e.g., defining a portion of a circle or ellipse, andsegments 146 connecting ends of the curved segments 144 to the centralregion 118. Alternatively, one or both of the outer curved segments 144may include a rounded tip (not shown) extending outwardly away from oneanother, e.g., as disclosed in the references incorporated by referenceelsewhere herein. The outer curved segments 144 may be connected to thecentral region 118 by one or more segments, e.g., relatively smallerradius segments 146 and substantially straight segments 148, as shown inFIG. 2D. Thus, each set of segments 144, 146, 148 may substantiallyenclose an open area 122 within the respective outer region 120.

Alternatively, the outer regions 120 may have different shapes than thatshown. For example, FIGS. 3A and 3B show an alternative embodiment of anapparatus 110′ including an implant 112′ having different dimensionsthan the implant 112, but otherwise similar in construction. In afurther alternative, the outer regions may have diamond shapes in arelaxed state, e.g., extending between the central region and relativelynarrow outer tips. In another alternative, the outer regions may havecircular or elliptical shapes, e.g., with or without the narrow tips. Instill another alternative, the outer regions may have generallytriangular shapes, e.g., within one of the apices of the trianglesoriented towards the central region and bases of the triangles definingouter ends of the implant. In yet another alternative, the outer regionsmay have generally rectangular, square, or other geometric shapes (notshown) that are larger than the narrower central region. In each ofthese alternatives, the open area 122 within the outer regions 120 maydefine a relatively large surface area, which may enhance appositionbetween the outer regions 120 and adjacent tissue.

Optionally, the open areas 122 of the implant 112 may include one ormore struts (not shown) extending across the open areas 122 and/or theopen areas 122 may be at least partially covered, e.g., with a flexiblemesh, fabric, braid, membrane or other material, as disclosed in thereferences incorporated by reference elsewhere herein.

As best seen in FIGS. 2D-2F, the implant 112 may be formed from asingle, continuous wire or other loop element 2014 that extends aroundthe outer periphery of the implant 112 to define the central region 118and outer regions 120 (including the segments 144-148). For example, theimplant 112 may be formed from a length of round, square, or othercross-section wire, e.g., having a diameter or other maximum dimensionof 0.010-0.015 inch.

In an exemplary embodiment, a wire may be bent or otherwise formed intothe desired shape and the ends may be coupled to one another. Forexample, as best seen in FIG. 2F, the ends of the wire 150 may beattached together at the central region 118 of the implant, e.g., laserwelded, sonic welded, soldered, heat sealed, and the like.Alternatively, the ends of the wire may be butt or lap welded and/orreceived and secured within a small tube (not shown) at the centralregion 118 or at another location of the implant 112, as desired. Theresulting shaped wire may be heat treated or otherwise treated toprogram in the desired shape and/or impart the desired elasticity and/orother properties into the resulting implant 112. Alternatively, theimplant 112 may be formed from multiple sections of wire attached insimilar manners. In a further alternative, the implant 112 may be formedfrom a sheet of material (not shown), e.g., by laser cutting, machining,etching, and the like, to remove sufficient material to provide the openareas, regions, and/or segments of the final implant, before or afterprogramming a desired shape into the sheet.

As shown in FIGS. 2A-2C, the sleeve 114 may be provided around at leasta portion of the central region 118, e.g., to cover the ends 150 and/orany welds or connection points of the wire forming the implant 112. Thesleeve 114 may be provided from a biocompatible plastic or metal, e.g.,polyetheretherketone (PEEK), and the like. For example, the sleeve 114may be provided from a tubular material cut to the desired lengthcorresponding to the central region 118, and directed over the wirebefore the wire is formed into the desired shape of the implant 112.Alternatively, the sleeve 114 may be directed over the wire aftershaping but before attaching the ends 150 of the wire. In a furtheralternative, the sleeve 114 may be provided from a sheet of materialthat may be wrapped around the central region 118 and attached togetherto secure the sleeve 114 around the central region 118. The sleeve 114may provide an increased surface area or profile for the central region,e.g., compared to the wire or other elements defining the central region118, to reduce the risk of tearing or other damage to other tissuethrough which the central region 118 is placed, and/or may reducefriction and/or enhance biocompatibility of the implant 112.

Turning to FIG. 1, with additional reference to FIGS. 4A and 4B, theapparatus 110 (and similarly any of the other embodiments describedherein) may be structured to be implanted and/or otherwise placed withinan oropharyngeal region 1 a of a patient 1. The central region 118 maybe positioned adjacent or within a posterior wall 2 d of theoropharyngeal region la and the outer regions 120 may extend outwardlyfrom the generally central region 118, e.g., around or within thelateral and/or anterior surface 2 g of the oropharyngeal region 1 a.

The implant 112 may be sufficiently resilient and/or elastic such thatone or both of the outer regions 120 may be collapsed vertically fromtheir relaxed state, e.g., as shown in FIGS.

2A and 2B, to a compressed state, e.g., as shown in FIG. 4A, whendirected through a relatively small opening, yet biased to resilientlyexpand back towards the relaxed state after passing through the opening.

Optionally, as shown in FIG. 4A, a needle 130 may be coupled to one ofthe outer regions 120, e.g., by a suture or other filament 132, toprovide a system for delivering the apparatus 2010 into theoropharyngeal region 1 a of a patient 1. The needle 130 may have a “U”or other shape to facilitate introduction through or behind a ligamentor other tissue structure adjacent the oropharyngeal region 1 a, and/orthe suture 132 may be a double suture looped through the needle 130 andouter region 120, as disclosed in the references incorporated byreference elsewhere herein.

Alternatively, other delivery devices (not shown) may be provided forfacilitating delivery of the implant 112, e.g., depending upon thetarget location for implantation. For example, a catheter, cannula, orother tubular member (not shown) may be provided within which theimplant 112 may be loaded, e.g., after manufacturing or immediatelybefore implantation. For example, a suture, tool, and the like (also notshown) may be coupled to one of the outer regions 120 and used to pullthe implant 112 into a lumen of a first end of a cannula, the outerregions 120 being resiliently compressed as the implant 112 is pulledtherein. As the implant 112 is pulled into the cannula, the implant 112may also be substantially straightened and/or otherwise elasticallydeformed. The implant 112 may be deployable from the cannula using aplunger or other pusher device within the cannula, e.g., adjacent theouter region 120 used to pull the implant 112 into the cannula.Alternatively, another suture, tool, and the like may be coupled to theouter region 120 closest to the first end of the cannula and used topull the implant 112 back out of the cannula, whereupon the outerregions 120 may resiliently expand and/or the implant 112 may beresiliently biased to return towards its relaxed state.

Referring now to FIGS. 4A and 4B, a generally “bowtie” shaped implant112, such as that shown in FIGS. 2A-2F, may be implanted into anoropharyngeal region of a patient using direct visualization and acurved, e.g., “U” shaped, needle 130 and suture 132. The suture 132 maybe tied to or otherwise coupled to either outer region 120 of theimplant 112 and/or through the needle 130, e.g., as described in thereferences incorporated by reference elsewhere herein. Alternatively,the implant 112 (or any of the other embodiments herein) may beimplanted using various imaging systems. For example, if at least aportion of the implant 112, e.g., central region 118 and/or tines orother features (not shown), are to be inserted into the ligament ALLand/or into a vertebra (not shown), the procedure may be monitored usingfluoroscopy, ultrasound ,or other external imaging. To facilitate suchmonitoring, optionally, the implant 112 may include one or more markersor other features, for example, radiopaque or echogenic markers, on thecentral region 118 and/or tines or other features (not shown).

Returning to FIGS. 4A and 4B, during implantation of the implant 112,the needle 130 may be introduced into the posterior wall of theoropharyngeal region and pushed through or behind the anteriorlongitudinal ligament “ALL” located anterior to the spine (althoughposterior to the oropharyngeal region), thereby creating a passage oropening. The needle 130 is then pulled out of the tissue along withsufficient length of suture 132 to allow it to be grasped and used topull the implant 112 through or behind the ligament ALL.

Using the suture 130, a first outer region 120 a of the implant 112 isthen pulled through the opening through or behind the ligament ALL withthe curve of the central region 118 facing in the anterior direction.The first outer region 120 a may be manually compressed, or may beresiliently compressed as it is pulled through or behind the ligament.Once the first outer region 120 a passes completely through or behindthe ligament ALL, the first outer region 120 a may resiliently expandtowards its relaxed state, as shown in FIG. 4B.

The implant 112 may be self-locating, e.g., in that it is shaped andstructured to gently unfold, expand, or otherwise spring into itsappropriate position once it has been correctly placed. Alternatively,the user may manipulate the implant 112 to ensure that the centralregion 118 and sleeve 114 are positioned across the ligament ALL and theouter regions 120 are positioned at least partially around or within thelateral surfaces of the oropharyngeal region. The suture 132 may be cutand removed, leaving the implant 112 in position such that the centralregion 118 remains within the opening through or behind the ligamentALL. The outer regions 120 may rest against the surface of the mucosallayer of the posterior, lateral, and optionally anterior walls of theoropharyngeal region, e.g., such that the opposite ends of the outerregions 120 rest against the tongue, depending on the length of theouter regions 120.

Optionally, if desired, the implant 112 may subsequently be removed fromthe patient, e.g., using a similar procedure used for implantation, asdisclosed in the applications incorporated by reference elsewhereherein.

FIG. 5 shows an alternative embodiment of an apparatus 210 including animplant 212 generally similar to the previous implants. For example, theimplant 210 may include a relatively narrow central region 218 betweenrelatively wide outer regions 220. Unlike the previous embodiments, thecentral region 218 includes one or more features for engaging ananterior longitudinal ligament and/or other tissue structure adjacent anoropharyngeal region or other location within which the implant 212 isintroduced for implantation.

For example, as shown, the implant 212 includes a pair of tines 214extending from the central region 218. The tines 214 may be biased toextend substantially perpendicularly to or otherwise transversely fromthe central region 218. The tines 214 may be elastically or plasticallydeformable, e.g., to open the tines 214 to accommodate receiving thetines 214 on either side of the ligament ALL. The tines 214 may then bereleased to resiliently return inwardly or may be plastically deformedinwardly to engage the ligament ALL, e.g., to enhance securely fixingthe implant 212 within an oropharyngeal region.

Alternatively, the tines 214 may be substantially rigid, e.g., such thatthe tines 214 may be penetrated into the ligament ALL and/or othertissue adjacent the oropharyngeal region within which the implant 212 isintroduced. For example, in an alternative embodiment, the tines 213 maybe sufficiently rigid and long, e.g., [______-______ mm] long, to extendthrough adjacent soft tissue and penetrate a vertebra adjacent theoropharyngeal region. Such rigid tines 214 may reduce the risk ofmigration of the implant 212 after implantation.

The tines 214 may include sharpened and/or pointed tips (not shown) tofacilitate penetration and/or may include barbs or other features, e.g.,similar to those shown in FIG. 9A, that may resist removal once thetines 214 are introduced into tissue, e.g., to enhance anchoring andresist migration of the implant 112.

In a further alternative, multiple sets of tines 214 or otherpenetrating or engaging features (not shown) may be provided. Forexample, if the implant includes a pair of spaced apart elements in therelatively narrow central region (e.g., as disclosed in the referencesincorporated by reference elsewhere herein), a set of tines may beprovided on each spaced apart element, which may be used to engage theligament ALL and/or penetrate into tissue adjacent the oropharyngealregion.

Turning to FIGS. 6A-8C, additional alternative embodiments of implants210 a-210 c are shown that include relatively narrow central regions 218a-218 c between relatively wide outer regions 220 a-220 c, generallysimilar to the previous embodiments. Unlike the previous embodiments,the implants 210 a-210 c have a different cross-section orthogonal tovertical axis 216 a-216 c, as best seen in FIGS. 6C, 7C, and 8C. In eachof these embodiments, the outer regions 220 a-220 c generally lie withina plane, except that, as they transition inwardly towards the centralregion 218 a-218 c, they may rise above the plane. The central region218 a-218 c defines a curved shape, e.g., defining a portion of a circleor ellipse that extends in a direction to intersect and descend belowthe plan, i.e., curve in an opposite direction to the outer regions 220a-220 c.

In this configuration, the central region 218 a-218 c may be shaped tobe introduced behind or through the ligament ALL, e.g., as describedabove with reference to FIGS. 4A and 4B). When the central region 218a-218 c is introduced behind or through the ligament ALL, the outerregions 220 a-220 c may be biased to a substantially planarconfiguration, but may adopt the curvature of the posterior and lateralwalls of an oropharyngeal region (not shown) within which the implant210 a-210 c is being implanted, e.g., to adopt a “C” shape. In thismanner, the outer regions 220 a-220 c may exert an outward force orotherwise treat the oropharyngeal region, similar to other embodimentsdescribed herein and in the applications incorporated by referenceherein.

The implants 210 a-210 c may be formed from a substantially flat sheet(not shown), e.g., from which the central region 218 a-218 c and outerregions 220 a-220 c may be laser cut, machined, etched, or otherwiseformed, similar to other embodiments herein. The shape of the implants210 a-210 c relative to the vertical axis 216 a-216 c may be programmedor otherwise set into the implant 210 a-210 c after being formed or intothe sheet before forming, as desired.

Also unlike the previous embodiments, the implants 210 a-210 c havedifferent configurations for the central region 218 a-218 c. Forexample, the implant 210 a shown in FIGS. 6A-6C may include a centralregion 218 a that includes a relatively wide band that curves around thevertical axis 216 a and extends between ends of the wire elementsdefining the outer regions 220 a. As shown, a rounded transition may beprovided between the ends of the wide band of the central region 218 aand the wire elements of the outer regions 220 a.

Alternatively, as shown in FIGS. 7A-7C, the central region 218 b mayinclude a relatively wide band that extends only partially between theouter regions 220 b. In this alternative, the wire elements defining theouter regions 220 b curve and extend substantially parallel to oneanother to partially define the central region 218 b. Thus, in thisalternative, the implant 210 b may provide greater flexibility betweenthe outer regions 220 b and the central region 218 b, e.g., tofacilitate vertical compression and/or folding, rolling, or otherdisplacement of the implant 210 b.

In the further alternative shown in FIGS. 8A-8C, the central region 218c includes a relatively wide band that has a smaller vertical heightthan the central region 218 a of the implant 210 a shown in FIGS. 6A-6C.Thus, the central region 218 c may also have greater flexibility thanthe central region 218 a.

Turning to FIG. 9, another embodiment of an implant 310 is shown thatincludes an elongate elliptical or other oval or oblong shaped bodydefining a length or major axis “M” between first and second ends (orouter regions) 322 and a width or minor axis “m,” e.g., at a centralregion 318 between the first and second ends 322. In an exemplaryembodiment, the implant 310 may be formed from a wire or sheet, whichmay be formed into the oval shape, similar to other embodiments herein.In a relaxed state, the implant 310 may be substantially planar, asshown, or alternatively, may have a curved shape, e.g., a “C” shapebetween the ends 322, similar to other embodiments herein and in thereferences incorporated by reference herein. The implant 310 may includean open area 322 surrounded by the wire or other material extendingaround a periphery of the implant 310. Optionally, the open area 322 mayinclude a flexible material, a mesh, supports, and the like (not shown),e.g., to support outer regions 322 of the implant 310 and/or enhancesurface contact with adjacent tissue.

As shown, the implant 310 includes two pairs of tines 314 disposedopposite one another, e.g., at the center of the central region 318.Similar to the previous embodiment, the tines 314 may be biased toextend substantially perpendicularly or otherwise transversely from thecentral region 318, e.g., out of the plane defined by the implant 310.The tines 314 may be elastically or plastically deformable, e.g., toopen the tines 314 to accommodate receiving the tines 314 on either sideof the ligament ALL. The tines 314 may then be released to resilientlyreturn inwardly or may be plastically deformed inwardly to engage theligament ALL, e.g., to enhance securely fixing the implant 312 within anoropharyngeal region.

Alternatively, the tines 314 may be substantially rigid, e.g., such thatthe tines 314 may be penetrated into the ligament ALL, a vertebra,and/or other tissue adjacent the oropharyngeal region within which theimplant 310 is introduced. Optionally, in this alternative, the tines314 may include sharpened tips, barbs, and/or other features, e.g., tofacilitate penetration into tissue and/or resist withdrawal oncepenetrated into tissue.

In a further alternative, shown in FIG. 9A, a single tine 314′ may beprovided instead of a pair of tines, e.g., on implants 310 or 212. Thetine 314′ may be penetrated into the ligament ALL, a vertebra (notshown), or other tissue structure, with the barb securing the tine 314′and, consequently, the implant relative to the tissue structure.

In further alternatives, other features may be provided on the implant310 (or any other embodiments herein or in the references incorporatedby reference herein) for securing the implant 310 relative to theligament ALL or other tissue structures. For example, connectors may beattached to or implanted into tissue within an oropharyngeal region orother target site where an implant is to be introduced. The implant mayinclude mating connectors that may engage the previously implantedconnectors when the implant is deployed within the target site.Exemplary connectors may include magnetic connectors, male-femalereceptacles, and the like (not shown). Alternatively, sutures or otherseparate fasteners (not shown) may be used to secure an implant within atarget site.

It will be appreciated that tines or other features may be provided onany of the implants, stents, or other apparatus disclosed in thereferences incorporated by reference elsewhere herein, e.g., to reducethe risk of migration and/or otherwise enhance stabilization of theapparatus after implantation. For example, features may be providedadjacent the ends or outer regions of the implant that may be penetratedinto tissue to stabilize the ends.

Turning to FIGS. 10A-12C, another embodiment of an implant 310 a isshown that includes a central region 318 a between outer regions 320 a,generally similar to previous embodiments. The outer regions 320 a maydefine a length of the implant 310 a, e.g., the distance between theopposite ends of the outer regions 320 a, and/or may define a height ofthe implant 310 a, e.g., the distance between lateral sides of the outerregions 320 a. In exemplary embodiments, the length may be between aboutten and one hundred millimeters (10-100 mm), or between about twenty andfifty millimeters (20-50 mm), and the height may be between about tenand one hundred millimeters (10-100 mm), or between ten and thirtymillimeters (10-30 mm). Thus, the implant 310 a may have an overallprofile (width-to-height relationship) that may range from generallyrectangular, elliptical, or oblong to square or circular.

As best seen in FIGS. 10A, 11A, and 12A, the central region 318 a may benarrow relative to the outer regions 320 a such that the central region318 a has a smaller height than the height of the outer regions 320 a.Similar to other embodiments, the implant 310 a may have a generally“bow-tie” shape with the outer regions 320 a including lobes defined bystruts surrounding and enclosing an open interior space 322 a. The outerregions 320 a may have a generally rectangular shape, as shown, e.g.,including outer segments 344 a extending between upper and lowersegments 346 a and connector segments 348 a extending between the upperand lower segments 346 a and the central region 318 a. The segments 344a-348 a may be substantially straight (e.g., as shown for segments 346a, 348 a) or may be curved (e.g., as shown for segments 344 a), and thebends between adjacent segments 344-348 a may be rounded, as shown, ormay be blunt (not shown), if desired.

As best seen in FIGS. 10A, 11A, and 12A, the central region 318 a mayinclude a pair of struts or elements 332 a extending along the length ofthe implant 310 a at least partially between the outer regions 320 a.The struts 332 a may be spaced apart from one another and coupledtogether by lateral struts 334 a, e.g., surrounding a central opening335, and may include flanges, rings, or other optional features 336 a tofacilitate manipulation of the implant 310 a, e.g., using a tool 350, asdescribed further below. The struts 332 a, 334 a may have a widthsubstantially greater than their thickness, which may be the same as thethickness of rest of the implant 310 a if the implant 310 a has asubstantially uniform thickness, e.g., to support the implant 310 awithin the plane of the implant 310 a while allowing displacement out ofthe plane. Optionally, the struts 332 a, 334 a may also have a widthgreater than the width of the segments 344 a-348 a, e.g., such that thecentral region 318 has a greater rigidity than the outer regions 320 a.However, the struts 332 a may accommodate bending, rolling, folding,displacement, or other manipulation of the implant 310 a out of theplane, e.g., between a substantially flat configuration, as shown inFIGS. 10A-11C, and a curved configuration, as shown in FIG. 12A-12C, anddescribed further below.

In addition, the implant 310 a may include one or more tines, struts,barbed portions, or other elements to enhance securing or anchoring theimplant 310 to tissue, e.g., to an anterior longitudinal ligament(“ALL”) or other tissue within an oropharyngeal region (not shown). Forexample, as shown in FIGS. 10A and 10C, the struts 332 a in the centralregion 318 a may include extensions 338 a that extend into the openinterior spaces 322 a of the outer regions 320 a. The extensions 338 amay be curved, as shown in FIGS. 11A-11C, out of the plane defined bythe implant 310 a, e.g., such that opposing extensions are curved, bent,or otherwise deformed back towards one another to define opposing pairsof tines 338 a. As shown, the implant 310 a includes two pairs ofopposing tines 338 a, although it will be appreciated that fewer or moretines (not shown) may be provided, if desired.

In an exemplary method for making the implant 310 a, a flat sheet ofmaterial, e.g., Nitinol or other elastic or superelastic material, maybe provided having a length and height at least as large as the implant310 a to be formed therefrom. Alternatively, other elastic materials maybe provided for the implant 310 a, e.g., stainless steel, Elgiloy,titanium or other metals, polymers, or composite materials. Regions ofthe sheet may be removed, e.g., by laser-cutting, machining, etching,stamping, and the like, to create the various features of the implant310 a, e.g., the struts 332 a, 334, tines 338 a, and segments 344 a-348a, as shown in FIGS. 10A-10C.

The tines 338 a may then be plastically deformed and/or heat set intothe curved shape shown in FIGS. 11A-11C. For example, the flat implant310 a may be mounted in a fixture, and the tines 338 a may be folded,curved, or otherwise directed around a mandrel into the desired curvedshape. The resulting assembly may then be heat treated to set the curvedshape into the tines 338 a. Thus, the implant 310 a may be biased to asubstantially flat configuration defining a plane with the tines 338 aextending out of that plane and/or partially back towards one another.

During use, the implant 310 a may be directed to a curved configuration,e.g., an “L” shaped or “C” shaped configuration, as shown in FIGS.12A-12C for introduction and/or implantation within an oropharyngealregion or other location within a patient's body (not shown). Onceimplanted within an oropharyngeal region, the outer regions 320 a may bebiased to return back towards the substantially flat configuration,thereby exerting a radially outward force on surrounding tissues,similar to other embodiments herein and in the references incorporatedby reference herein.

Optionally, a tool may be provided to facilitate directing the implant310 a between the substantially flat and curved configurations and/orotherwise introducing the implant 310 a into an oropharyngeal region.FIGS. 13A-13C show an exemplary embodiment of a tool 350 that includesan elongate shaft 352 including a proximal end 354 for manipulating thetool 350 and a distal end 354 sized for carrying an implant, such asimplant 310 a. The distal end 354 of the tool 350 may be sized forintroduction into a patient's body, e.g., through the patient's mouthinto the oropharyngeal region, and/or may include one or more featuresfor releasably securing the implant 310 a to the tool 350.

For example, in one embodiment, best seen in FIGS. 13B and 13C, thedistal end 356 may include a rounded tip or knuckle 360 against whichthe central region 318 a of the implant 310 a may be placed and/orsecured. The rounded tip 360 may have a radius of curvaturecorresponding to a desired radius of curvature for the central region318 a when the implant 310 a is directed from the substantially flat tothe curved configuration.

The distal end 356 may also include one or more features for engagingthe implant 310 a, e.g., the rings 336 a on the lateral struts 334 a, tosecure the implant 310 a to the distal end 356, e.g., in the curvedconfiguration. For example, one or more filaments or rods (not shown)may be directed through the rings 336 a and secured to the distal end356 of the tool 350, e.g., to posts 362 proximal to the distal tip 356.In one embodiment, one or more rods may be directed through each ring336 a, and through an aperture in the corresponding post 362, and therod(s) may be retracted to cause the implant 310 a to deflect into thecurved configuration. Alternatively, a single filament may be directedthrough both rings 336 a and posts 362, which may be tightened to securethe implant 310 a in the curved configuration.

It will be appreciated that, as the implant 310 is directed from thesubstantially flat configuration to the curved configuration, theopposing pairs of tines 338 a may be directed away from one another toopen a space therebetween, as best seen in FIGS. 11B, 11C, 12B, and 12C.

Ends of the rod(s) or filament(s) may be fixed relative to the posts 362to prevent the rods from releasing the implant 310 a. When it is desiredto release the implant 310 a from the tool 350, e.g., after introductioninto the oropharyngeal region of a patient, the rods may be used todrive the tines into the tissue then released from the rings 336 a andremoved.

Alternatively, the distal end 356 of the tool 350 may include otheractuatable features that may be engaged with the rings 336 a and/orotherwise with the implant 310 a. For example, a pair of hooks (notshown) may be provided adjacent the distal tip 360 that may be movablebetween two or more positions for releasably securing the implant 310 aand/or directing the implant 310 a between the substantially flat andcurved configurations. The hooks may have a relatively low profileand/or substantially atraumatic tips to allow engagement with the rings336 a while minimizing contact with surrounding tissue duringintroduction of the implant 310 a into a patient's body.

In a first or distal position, the hooks may be disposed adjacent thedistal tip 360 and spaced apart such that the hooks may be received inrespective rings. The hooks may then be directed to a secondintermediate position, e.g., directing the hooks outwardly away from oneanother and/or proximally, to secure the inner region 318 a of theimplant 310 a against the distal tip 360 with the implant 310 a still inthe substantially flat configuration (or slightly curved, if it isdesired to maintain a slight tension on the implant 310 a). Whendesired, the hooks may be directed to a third proximal position, whereinthe rings 336 a are pulled proximally and/or wound around the distal tip360 to direct the implant 310 a to the curved configuration.Alternatively, the hooks may actuated directly between the first andthird positions, if desired.

Also when desired, the hooks may be directed back to the second and/orfirst positions to release the implant 310 a, e.g., within anoropharyngeal region. For example, the implant 310 a, carried on thedistal end 356 of the tool 350 in the curved configuration, may beintroduced through a patient's mouth into the oropharyngeal region. Withthe tines 338 a oriented towards the posterior wall of the oropharyngealregion, the implant 310 a may be at least partially released, e.g., bydirecting the hooks to the second or first position, to drive the tines338 a into tissue adjacent the posterior wall, e.g., into or behind theligament ALL, similar to other embodiments. For example, as the implant310 a is partially released, the implant 310 a may resiliently attemptto return towards the substantially flat configuration, therebydirecting the opposing tines 338 back towards one another, penetratingand/or otherwise capturing tissue therebetween.

Alternatively, the tines 338 a may be driven into tissue with theimplant 310 a maintained in the curved configuration. For example, theimplant 310 a may be held in the curved configuration by the hooks, andthe tool 350 may be advanced to forcefully drive the tines 338 a intothe tissue. Once the tines 338 a are sufficiently advanced into tissue,the tool 350 may be directed to the second or first positions, therebyreleasing the implant 310 a towards the flat configuration and,optionally, further driving the tines 338 a into the tissue anddirecting the outer regions 320 a against the lateral and/or anteriorwalls of the oropharyngeal region. The implant 310 a may then be fullyreleased, and the tool 350 removed.

Optionally, the proximal end 354 may include one or more actuators (notshown) for controlling the features of the distal end 356, e.g., todirect the implant 310 a between the substantially flat and curvedconfigurations and/or to release the implant 310 a from the distal end356. For example, if the tool 350 includes hooks, a trigger or slider(not shown) may be provided on the proximal end 354 that is mechanicallycoupled to the hooks for directing the hooks between the first and thirdpositions.

Optionally, the tool 350 may include one or more features for changingan orientation of the distal end 356. For example, as best seen in FIGS.13B and 13C, the distal end 356 may include a bendable portion 364 thatmay be selectively directed to one or more angles relative to alongitudinal axis of the shaft 352. For example, the bendable portion364 may be a substantially rigid segment coupled to the shaft 352 by ahinge or other pivot point 366. An actuator, e.g., slider 368, may beprovided on the proximal end 354 that is mechanically coupled to thebendable portion 364. The slider 368 may be directable between a firstor distal position in which the bendable portion 364 is substantiallycoaxial with the longitudinal axis of the shaft 352, e.g., such that thetool 350 is substantially straight, and a second or proximal position inwhich the bendable portion 364 is rotated to a maximum bend angle, e.g.,less than ninety degrees)(90°) relative to the longitudinal axis of theshaft 352. The slider 368 may be directable to any location between thefirst and second positions, e.g. to orient that implant 310 a at anydesired angle relative to the shaft 352, which may facilitateintroduction and/or orientation of the implant 310 relative to theoropharyngeal region of the patient.

Alternatively, other features may be provided to allow adjustment of theorientation of the implant 310 a relative to the shaft 352. For example,the distal end 356 may be malleable such that the user may deform thedistal end 356 to a desired orientation, which the distal end 356 willmaintain until otherwise deformed. In a further alternative, the distalend 356 may be semi-rigid or flexible and the tool 350 may include oneor more steering cables (not shown) within the shaft 352 that mayactuated to direct the distal end 356 into a desired shape, e.g., asimple curve or a more complicated multiple curved shape, if desired.

Turning to FIGS. 19A-19C, another embodiment of an implant 810 is shownthat includes a central region 818 between outer regions 820, generallysimilar to previous embodiments. The outer regions 820 may define alength of the implant 810, e.g., the distance between the opposite endsof the outer regions 820, and/or may define a height of the implant 810,e.g., the distance between lateral sides of the outer regions 820, alsosimilar to previous embodiments.

As shown, the central region 818 may be narrow relative to the outerregions 820 such that the central region 818 has a smaller height thanthe height of the outer regions 820. Similar to other embodiments, theimplant 810 may have a generally “bow-tie” or “'butterfly” shape withthe outer regions 820 including lobes defined by struts surrounding anenclosing an open interior space 822. Unlike the previous embodiments,each of the outer regions 820 includes a pair of flanges or lobes 821,i.e., an upper flange or lobe and a lower flange or lobe, that aremovable at least partially independently from one another.

For example, as shown, each flange or lobe 821 may include generallyhorizontal outer and inner segments 844, 846 extending between generallyvertical end segments 848, 849 and connector segments 849 extendingbetween the outer and inner segments 844, 846 and the central region818, thereby defining the open interior space 822. The segments 844-849may be substantially straight and/or curved, and the bends betweenadjacent segments 844-849 may be rounded, as shown, or may be blunt (notshown), if desired.

As shown, the central region 818 may include a pair of struts orelements 832 extending lengthwise along the implant 810 between theouter regions 820. The struts 832 may be spaced apart from one anotherand coupled together by lateral struts 834, which may include flanges,rings, or other optional features 836 to facilitate manipulation of theimplant 810, e.g., using a tool (not shown), similar to previousembodiments. The struts 832, 834 may have a width substantially greaterthan their thickness (which may be the same as the thickness of the restof the implant 810 if the implant 810 has a substantially uniformthickness). Optionally, the struts 832, 834 may also have a widthgreater than the width of the segments 844-849, e.g., such that thecentral region 318 has a greater rigidity than the outer regions 320 a.However, the struts 832 may accommodate bending, rolling, folding,displacement, or other manipulation of the implant 810, e.g., between asubstantially flat configuration, as shown in FIG. 19A, and a curvedconfiguration, as shown in FIG. 19C, and described further below.

In addition, the implant 810 may include one or more tines, struts,barbed portions, or other elements to enhance securing or anchoring theimplant 310 to tissue, e.g., to an anterior longitudinal ligament(“ALL”), vertebra, or other tissue within an oropharyngeal region (notshown). For example, as shown, the struts 832 in the central region 818may include tines 838 that extend into the open interior spaces 822 ofthe outer regions 320 a. The tines 838 may be curved, as shown in FIGS.19B and 19C, out of a plane defined by the implant 810 in a relaxedstate, e.g., such that opposing extensions are curved, bent, orotherwise deformed back towards one another to define opposing pairs oftines 838. As shown, the implant 810 includes two pairs of opposingtines 838, although it will be appreciated that fewer or more tines (notshown) may be provided, if desired. Alternatively, the tines may beoriented in other configurations, e.g., substantially perpendicular tothe plane of the implant 810 in the relaxed state or away from oneanother, as described elsewhere herein.

Similar to other embodiments, the implant 810 may be formed from a flatsheet of material, e.g., Nitinol or other elastic or superelasticmaterial, having a length and height at least as large as the implant810 to be formed therefrom. Regions of the sheet may be removed, e.g.,by laser-cutting, machining, etching, and the like, to create thevarious features of the implant 810. The tines 838 may then beplastically deformed and/or heat set into the curved shape shown inFIGS. 19B and 19C. For example, the flat implant 810 may be mounted in afixture, and the tines 838 may be folded, curved, or otherwise directedaround a mandrel into the desired curved shape. The resulting assemblymay then be heat treated to set the curved shape into the tines 838.Thus, the implant 810 may be biased to a substantially flatconfiguration defining a plane with the tines 838 extending out of thatplane and/or partially back towards one another.

During use, the implant 810 may be directed to a curved configuration,e.g., as shown in FIG. 19C, using a tool (not shown), for introductionand/or implantation within an oropharyngeal region or other locationwithin a patient's body (not shown). As the implant 810 is directed fromthe substantially flat configuration to the curved configuration, theopposing pairs of tines 838 may be directed away from one another toopen a space therebetween. The tines 838 may then be penetrated intotissue, e.g., adjacent or through the ligament ALL, vertebra, and/orother tissue adjacent the oropharyngeal region, and the implant 810 maythen be released, similar to other embodiments herein.

Once implanted within an oropharyngeal region in the curvedconfiguration, the outer regions 820 may be biased to return backtowards the substantially flat configuration, thereby exerting aradially outward force on surrounding tissues, similar to otherembodiments herein and in the references incorporated by referenceherein. The separate flanges or lobes 821 of each outer region 820 mayprovide greater apposition with surrounding tissue and/or flexibility,e.g., to enhance dilation of the surrounding tissue while accommodatingswallowing or other movement of the tissue.

Turning to FIGS. 20A-20C, another embodiment of an implant 910 is shownthat includes a relatively narrow central region 918 between outerregions 920 lying generally within a plane to define a substantiallyflat configuration, generally similar to previous embodiments. Unlikethe implant 810, the implant 910 includes tines 938 that extendvertically substantially parallel to its vertical axis 916, i.e.,orthogonal to the length or major axis of the implant 910, as shown inFIG. 20A. The tines 938 may be plastically deformed and/or heat set tocurve out of the plane of the implant 910 and towards one another, asshown in FIG. 20B, similar to other embodiments herein. Thus, tips ofthe opposing pairs of tines 938 may be oriented towards one another whenthe implant 910 is in its relaxed configuration. As shown, opposing tipsof the tines 938 are aligned with and spaced apart slightly from oneanother, although alternatively the tips may be offset from one anotherand/or may extend between the opposing tines 938 (not shown), ifdesired.

In addition, each of the outer regions 920 includes a pair of flanges orlobes 921 that have a greater height than the central region 918, e.g.,to provide greater contact area with adjacent tissue when implantedwithin an oropharyngeal region (not shown). Optionally, as shown, theflanges 921 may include supplemental struts 947 that extend across theopen interior spaces 922 of the respective flanges 921. These struts 947may enhance the stiffness of the flanges 921, while allowing them someindependent motion relative to one another, and/or may enhance surfacecontact with adjacent tissue when the implant 910 is implanted.

During use, the implant 910 may be directed to a curved configurationalong the length of the implant 910 or about its horizontal axis 917,e.g., as shown in FIG. 20C, using a tool (not shown) similar to theprevious embodiments, for introduction and/or implantation within anoropharyngeal region or other location within a patient's body (notshown). As the implant 910 is directed from the substantially flatconfiguration to the curved configuration, the opposing pairs of tines938 may be directed away from one another to open a space therebetween.The tines 938 may be penetrated into tissue, e.g., adjacent or throughthe ALL, and the implant 910 may then be released.

Turning to FIGS. 21A-21D, another embodiment of an implant 1010 is shownthat includes a relatively narrow central region 1018 between outerregions 1020 lying generally within a plane to define a substantiallyflat configuration, and opposing pairs of tines 1038, generally similarto previous embodiments. Similar to other embodiments herein, thecentral region 1018 may include one or more struts or elements 1032,1034 surrounding a central opening 1035. The struts 1032, 1034 maysupport the outer regions 1020 and/or tines 1038, similar to otherembodiments herein.

Each of the outer regions 1020 defines a flange or lobe 1021 that has agreater height (along the vertical or minor axis of the implant 1010)than the central region 1018 and surrounds an open interior space 1022,e.g., to provide greater contact area with adjacent tissue whenimplanted within an oropharyngeal region (not shown). Alternatively, asshown in FIGS. 22A-22D, each of the outer regions 1020′ of the implant1010′ may include multiple lobes 1021′, e.g., a pair of lobes 1021′defining a generally butterfly shape. As shown, the lobes 1021, 1021′include supplemental struts 1047, 1047′ that extend across the openinterior spaces 1022, 1022′. These struts 1047, 1047′ may enhance thestiffness of the lobes 1021, 1021′ while allowing them some independentmotion relative to one another, and/or may enhance surface contact withadjacent tissue when the implant 1010, 1010′ is implanted, similar toother embodiments herein.

As best seen in FIGS. 21C and 21D, the outer regions 1020, e.g., thelobes 1021 and/or struts 1047, may extend slightly out of the plane ofthe implant 1010, yet are still considered to define a substantiallyflat configuration as used herein. For example, horizontal struts 1044and/or vertical struts 1048 defining the lobes 1021 and the supplementalstruts 1047 may curve slightly out of the plane of the implant 1010,e.g., to enhance the rigidity of the implant 1010 while accommodatingmovement of the lobes 1021, for example, during normal movement of theoropharyngeal region within which the implant 1010 is implanted.

As shown in FIG. 21B, the implant 1010 may be formed from asubstantially flat sheet, e.g., with the lobes 1020 and tines 1038 lyingsubstantially within a plane. Similar to the implant 910, the tines 1038extend vertically from the central region 1018, i.e., orthogonal to thelength or major axis of the implant 1010. Unlike the implant 910, thetines 1038 may be plastically deformed and/or heat set to curve out ofthe plane of the implant 910 and away from another, as shown in FIGS.21A and 21D, using similar methods to other embodiments herein. Forexample, the opposing pairs of tines 1038 may curve transversely out ofthe plane of the implant 1010, e.g., with the tips orientedsubstantially parallel to but offset from the plane of the implant 1010.Alternatively, the tines 1038 may be oriented horizontally relative tothe outer regions (not shown), e.g., similar to other embodimentsherein.

During use, the tines 1038 may be directed to a substantially straightand/or transverse configuration, e.g., extending substantiallyperpendicular to the plane of the implant 1010 to facilitate penetrationinto tissue. For example, the tines 1038 may be resiliently directed tothe substantially straight and/or transverse configuration, withoutsubstantially displacing the rest of the implant 1010, e.g., the outerregions 1020, from the flat configuration, unlike previous embodiments.Alternatively, if desired, the outer regions 1020 may also be displaced,e.g., to direct the implant 1010 to a curved configuration, tofacilitate introduction into a patient's mouth and oropharyngeal region,similar to other embodiments herein.

Turning to FIGS. 23A-25B, an exemplary embodiment of a tool 1050 isshown that includes an elongate shaft 1051 for carrying the implant1010, e.g., in the substantially flat configuration, and a deliverymember 1070 for deploying the implant 1010 from the shaft 1051.Generally, the shaft 1051 includes a proximal end 1054 for manipulatingthe tool 1050 and a distal end 1054 for carrying an implant, such asimplant 1010. The distal end 1054 of the tool 1050 may be sized forintroduction into a patient's body, e.g., through the patient's mouthinto the oropharyngeal region, and/or may include one or more featuresfor releasably securing the implant 1010 to the tool 1050.

For example, as shown, the distal end 1054 may include a pair ofsubstantially rigid fingers or rods 1060 spaced apart from one anotherby a predetermined distance, e.g., corresponding to the height of thecentral region 1018 of the implant 1010. Thus, the implant 1010 may beloaded onto the distal end 1054 of the tool 1010 by sliding the centralregion 1018 between the fingers 1060 with the outer regions 1020 oneither side of the fingers 1060, as best seen in FIG. 23A. During thisaction, the tines 1038 (which are biased to extend outwardly away fromone another, as described above and as shown in FIGS. 24A and 25A) mayslidably engage inner surfaces of the fingers 1060, causing the tines1038 to be elastically constrained in a substantially straight and/ordistal orientation wherein the tips of the tines 1038 are closer than intheir relaxed transverse orientation. Thus, the fingers 1060 mayconstrain the tines 1038 generally perpendicular to the plane of theimplant 1010 and/or generally parallel to a longitudinal axis 1056 ofthe tool 1050 (although there may be some remaining curve in the tines1038 when constrained in the substantially straight orientation, as bestseen in FIG. 23B), which may facilitate delivery of the tines 1038 intotissue, as described further below.

The fingers 1060 may be sufficiently wide and/or otherwise shaped toslidably engage the outer regions 1020 of the implant 1010, e.g., toprevent lateral and/or rotational movement of the implant 1010 relativeto the distal end 1054 of the tool 1050. Thus, the fingers 1060 maysupport the implant 1010 substantially stationary relative to the distalend 1054 during introduction. Alternatively, the tool 1050 may includeone or more additional features to anchor or further secure the implant1010 to the distal end 1054, e.g., one or more filaments, detents, andthe like (not shown), which may engage one or more struts of the implant1010. The features may remain engaged with the implant 1010 duringintroduction into a patient's mouth and oropharyngeal region, e.g.,until immediately before the implant 1010 is to be released from thetool 1050, whereupon the features may be disengaged, e.g., using anactuator (not shown) on the proximal end 1052 of the tool 1050, toprepare the implant 1010 for delivery.

The delivery member 1070 may be a plunger or other elongate memberslidable distally relative to the shaft 1051. For example, as best seenin FIG. 23B, the shaft 1051 may include a passage 1058 extending betweenthe proximal and distal ends 1052, 1054 that may slidably receive thedelivery member 1070. The delivery member 1070 generally includes aproximal end 1072 that extends proximally from the proximal end 1052 ofthe shaft 1051, and a distal end 1074 that may be disposed adjacent thefingers 1060. For example, in a first or proximal position, shown inFIGS. 23A and 23B, the distal end 1074 may be disposed proximal to thefingers 1060 so as not to interfere with loading the implant 1010between the fingers 1060. The delivery member 1070 may then be advancedto a second or distal position, wherein the distal end 1074 passesbetween the fingers 1060, e.g., to advance and deploy the implant 1010distally from the fingers 1060, as described further below.

Optionally, the tool 1050 may include one or more features for changingan orientation of the distal end 1054. For example, the distal end 1054may include one or more hinges or other bendable features (not shown)that may be selectively directed to one or more angles relative to thelongitudinal axis 1056 of the shaft 1051. An actuator (not shown) may beprovided on the proximal end 1052 that is mechanically coupled to thebendable feature(s). Alternatively, the distal end 1054 may be malleablesuch that the user may deform the distal end 1054 to a desiredorientation, which the distal end 1054 will maintain until otherwisedeformed. In this alternative, the delivery member 1070 may besufficiently malleable or flexible to accommodate such bending whilestill being able to slide axially relative to the shaft 1051.

During use, the implant 1010 may loaded onto the tool 1050, e.g.,between the fingers 1060, as described above and shown in FIGS. 23A and23B. The implant 1010 may be provided loaded on the tool 1050 by themanufacturer, or may be loaded onto the tool 1050 by a user, e.g.,immediately before implantation into a patient, for example, to minimizethe time that the tines 1038 are constrained in the distal orientation.

The implant 1010 carried on the distal end 1054 of the tool 1050 withthe tines 1038 constrained by the fingers 1060 may be introduced througha patient's mouth into the oropharyngeal region. The fingers 1060 may bedirected towards the posterior wall of the oropharyngeal region, e.g.,pressed against the surrounding tissue, whereupon the delivery member1070 may be advanced to deploy the implant 1010. As the delivery member1070 is advanced, the tines 1038 may extend beyond the tips of thefingers 1060 and thereby necessarily penetrate into the adjacent tissuesat locations immediately adjacent fingers 1060. As the tines 1038 areextended beyond the fingers 1060, the tines 1038 may resiliently expandaway from one another, e.g., to open transversely as they penetrate intothe adjacent tissues. Thus, the tines 1038 may attempt to return towardstheir relaxed, transverse orientation as they are directed into thetissue, until the implant 1010 is fully deployed beyond the fingers1060. In this manner, the implant 1010 may be implanted directly againstthe wall of the oropharyngeal region with the tines 1038 extendingoutwardly away from one another to secure the implant 1010 relative tothe tissue.

In an alternative embodiment, an implant may be provided that isgenerally similar to the implant 1010, except that the tines 1038 may bebiased to extend inwardly towards one another (not shown). For example,the tines may be offset from one another such that the tines cross oneanother rather than away from one another, as shown in FIG. 21D. In thisalternative, a tool similar to tool 1050 may be used to carry theimplant with the tines constrained in a substantially straight and/ordistal orientation. For example, the tool may include one or morefeatures that extend through the central opening in the central regionof the implant (not shown) that may slidably engage the tines and directthe tines from the relaxed, crossed orientation to the substantiallystraight and/or distal orientation. Thus, when the implant is deployedfrom the tool within the oropharyngeal region of a patient, the tinesmay be driven into tissue and allowed to resiliently cross and/or returntowards their relaxed orientation, thereby securing the implant totissue adjacent the oropharyngeal region.

In further alternatives, an implant may be provided that includesplastically deformable tines, e.g., initially provided in asubstantially straight and/or distal orientation substantiallyperpendicular to the plane of the implant. For example, the implant maybe carried by a tool that may include a hammer and anvil structure,similar to surgical staplers, disposed adjacent the tines. During use,as the tines are directed into tissue, the tool may be actuated toplastically deform the tines to direct them towards a transverseorientation, for example, towards one another, e.g., with or withoutcrossing, or away from one another. The implant may be carried by thetool in its substantially flat configuration, or the outer regions maybe displaced, e.g., to a curved configuration, to facilitateintroduction into the oropharyngeal region or other implantation site.

Turning to FIGS. 26A and 26B, another embodiment of an implant 1110 isshown that includes a relatively narrow central region 1118 betweenouter regions 1120 lying generally within a plane to define asubstantially flat configuration. Similar to other embodiments, thecentral region 1118 may include one or more struts or elements 1132,1134, e.g., surrounding a central opening 1135. Unlike some of theprevious embodiments, the central region 1118 includes one or more rings1036 formed on struts 1132 that defines apertures 1136 a, e.g., forreceiving one or more fasteners 1178, as described further below.

Each of the outer regions 1120 defines a flange or lobe 1121 that has agreater height (along the vertical or minor axis of the implant 1110)than the central region 1118 and surrounds an open interior space 1122,e.g., to provide greater contact area with adjacent tissue whenimplanted within an oropharyngeal region (not shown). Alternatively,each of the outer regions 1120 of the implant 1110 may include multiplelobes, e.g., a pair of lobes defining a generally butterfly shape (notshown), similar to other embodiments herein. As shown, the lobes 1121include supplemental struts 1147 that extend across the open interiorspaces 1122, e.g., to enhance the stiffness of the lobes 1021, whileallowing them some independent motion relative to one another, and/or toenhance surface contact with adjacent tissue when the implant 1110 isimplanted, similar to other embodiments herein. The implant 1110 may beconstructed generally using similar materials and methods to otherembodiments herein.

During use, the implant 1110 may be introduced into an oropharyngealregion with the implant in its substantially flat relaxed configuration,or rolled or otherwise displaced into a curved configuration, similar toother embodiments herein. With the implant 1110 positioned at a desiredlocation, e.g., against the tissue adjacent the posterior wall of theoropharyngeal region, one or more fasteners 1178 may be delivered tosecure the implant 1110 to the tissue. For example, as shown, a fastener1178 may be directed through each aperture 1136 a into the tissue tosecure the central region 1118 to the tissue. The fastener(s) 1178 maybe have a “U” shape in its relaxed state or other shape, e.g., withcrossed legs, legs oriented away from one another, and the like (notshown). For example, the fastener(s) 1178 may be formed from elastic orsuperelastic material, plastically deformable material, and the like.Alternatively, sutures or other fasteners (not shown) may be directedthrough the apertures 1136 a into adjacent tissue to secure the implant1110, e.g., as described elsewhere herein and in the referencesincorporated by reference herein.

Turning to FIGS. 14A and 14B, additional embodiments of implants 510,510′ are shown that include a central region 518, 518′ between outerregions 520, 520, generally similar to previous embodiments. As shown,the outer regions 520, 520′ may have a greater height than the centralregion 518, 518′, e.g., to define a generally “bow-tie” shape, alsosimilar to previous embodiments. The central region 518, 518′ mayinclude a strut or other anchoring element 514, 514′ extending at leastpartially between the outer regions 520, 520′ that includes a fixed end514 a, 514 a′ coupled to one of the outer regions 520, 520′, and a freeend 514 b, 514 b′ disposed adjacent the opposite outer region 520, 520′.

The implant 510, 510′ may be formed from a substantially flat sheet,e.g., by laser-cutting, machining, etching, or otherwise forming theelements of the central region 518, 518′ and outer regions 520, 520′from the sheet, similar to other embodiments. As shown in FIG. 14A, theouter regions 520 may include substantially continuous surface lobes 521that are coupled together, e.g., by one or more links 519, 523. Forexample, as shown, one pair of lobes 521 defining first outer regions520 may be coupled together by lateral link 523, and each of those lobes521 may be coupled to a lobe 521 of the opposite second outer region 520by longitudinal links 519 that extend through the central region 518. Inthis embodiment, the lobes 521 of the second outer region 520 may beseparate from one another, e.g., to accommodate the free end 514 b ofthe strut 514. Alternatively, as shown in FIG. 14B, the outer regions520′ may be defined by peripheral struts such that the lobes 521′include open interior regions 522′.

The implant 510, 510′ may be biased to a substantially flatconfiguration defining a plane, yet may be resiliently directed to acurved configuration, e.g., for introduction and/or implantation,similar to other embodiments herein. The strut 514, 514′ may also liewithin the plane, yet may be resiliently directed out of the plane,e.g., to facilitate directing the strut 514, 514′ through tissue, asdescribed further below. Alternatively, the strut 514, 514′ may bebiased to extend out of the plane.

For example, the strut 514, 514′ may be biased to curve out of the planeand back towards the plane, e.g., such that a midportion of the strut514, 514′ is disposed furthest away from the plane and the free end 514b, 514 b′ is disposed within or adjacent the plane. In a furtheralternative, the strut 514, 514′ may be biased such that the fixed end514 a, 514 a′ curves or bends out of the plane, and the free end 514 b,514 b′ extends substantially parallel to the plane. In a furtheralternative, the implant 510, 510′ may be biased to a “C” or othercurved configuration, and the strut 514, 514′ may be biased to extendout of the curved plane defined by the implant 510, 510′, similar to theconfigurations described above.

During use, the implant 510, 510′ may be directed into a curvedconfiguration, e.g., by rolling, folding, or otherwise directing theouter regions 520, 520′ out of plane towards one another, and thenintroduced into a target lumen. For example, the implant 510, 510′ maybe introduced through a patient's mouth into an oropharyngeal region(not shown), e.g., such that the central region 518, 518′ is disposedadjacent the posterior wall of the oropharyngeal region. One or morevertical incisions may be created in the posterior wall, e.g., throughor behind the anterior longitudinal ligament (“ALL”), and the strut 514,514′ may be inserted through the incision(s), e.g., to substantiallysecure the implant 510, 510′ relative to the posterior wall.

In an exemplary embodiment, an incision may be created that extendsthrough or behind the ligament ALL and has a height similar to a widthof the strut 514, 514′. Optionally, as shown in FIG. 14B, the free end514 b′ of the strut 514′ may have a width greater than the main portionof the strut 514′, e.g., wider than the height of the incision. In thisembodiment, the free end 514 b′ may be resiliently compressible, e.g.,to reduce its width and accommodate insertion of the strut 514′ throughthe incision. Once the free end 514 b′ is exposed on the other side ofthe incision, the free end 514 b′ may be allowed to resiliently expandback to its original width, e.g., to provide a support that resists thestrut 514′ being pulled back out through the incision.

Thus, the implant 514, 514′ may be implanted within an oropharyngealregion with the central region 518, 518′ disposed against the posteriorwall and the outer regions 520, 520′ providing an outward force, e.g.,against the lateral walls of the oropharyngeal region, similar to otherembodiments herein. With the strut 514, 514′ extending through theincision, the implant 510, 510′ may be substantially secured, therebypreventing migration or other undesired movement. If desired, theimplant 510, 510′ may be subsequently removed, e.g., by compressing thefree end 514 b, 514 b′ and withdrawing the strut 514, 514′ from theincision, and then removing the implant 510, 510′.

Turning to FIGS. 15A-15D, alternative embodiments of implants 610 areshown that include one or more anchoring struts 614 that maysubstantially secure the implants 610 within a patient's body, e.g.,within the oropharyngeal region with the strut(s) inserted intocorresponding incision(s) through or behind the ligament ALL or othertissue on the posterior wall of the oropharyngeal region. The implantsmay be formed flat sheets, and/or by one or more wires or otherelements, similar to other embodiments herein and in the applicationsincorporated by reference herein.

For example, FIG. 15A shows an implant 610 a that includes multiplehorizontal struts 612 a, 614 a oriented opposite one another. Forexample, upper and lower struts 612 a may define an outer periphery ofthe implant 610 a and include tips that are oriented opposite a tip ofanchoring strut 614 a. Thus, during implantation, the anchoring strut614 a may be inserted into/through an incision, e.g., in the posteriorwall of an oropharyngeal region, and the upper and lower struts 612 amay engage the outer surface of the posterior and lateral walls of theoropharyngeal region.

FIG. 15B shows another embodiment of an implant 610 b that includes wireor other elements 612 b defining an outer periphery of the implant 612b, e.g., surrounding an open interior space 622 b, and anchoring struts614 b that extend vertically from the outer periphery at least partiallyacross the interior space 622 b. As shown, the struts 614 b extendpartially across the height of the implant 610 b, i.e., which may beshorter than the length of the implant 610 b. During use, the implant610 b may rolled, folded, or otherwise directed to a curvedconfiguration, e.g., about its length, and introduced into anoropharyngeal region. The struts 614 b may be inserted into verticalincisions, e.g., in the posterior or lateral walls of the oropharyngealregion, to reduce the risk of migration of the implant 610 b oncereleased. Optionally, as shown, the struts 614 b may include enlargedfree ends, which may enhance securing the implant, e.g., if the enlargedfree ends are inserted through and out of the vertical incisions.

FIG. 15C shows another embodiment of an implant 610 c that includes anouter periphery 612 c surrounding an open interior space 622 c and apair of curved anchoring struts 614 c offset from one another. In thisembodiment, the struts 614 c may be inserted into or through respectiveincisions (not shown), e.g., by rotating the implant 610 c to directfree ends (which may include enlarged regions, if desired) of the struts614 c into or through the incisions.

FIG. 15D shows still another embodiment of an implant 610 d thatincludes an outer periphery 612 d defining a relatively narrow centralregion 618 d between outer regions 620 d. The outer regions 620 dsubstantially surround open interior spaces 622 d, and anchoring struts614 d extend vertically at least partially across respective interiorspaces. Thus, the struts 614 d may be inserted into or throughincisions, e.g., in the posterior wall of an oropharyngeal region tosubstantially secure the implant 610 d therein.

In each of these alternatives, it will be appreciated that the implants610 may be biased to substantially flat or curved configurations, andthat the struts 614 may lie within the plane of the implants 610 or mayextend out of the plane, similar to other embodiments herein. The struts614 may be oriented vertically, e.g., for insertion into horizontalincisions in tissue, or may be oriented horizontally, e.g., for incisioninto vertical incisions in tissue, for example, into or behind theanterior longitudinal ligament adjacent the posterior wall of theoropharyngeal region.

Turning to FIG. 16, still another embodiment of an implant 710 is shownthat generally includes a relative narrow central region 718 betweenlobes defining outer regions 720, similar to other embodiments herein.The central region 718 may include horizontal struts 732 that couple theouter regions 720 together, and one or more anchoring struts 734 thatextend partially across the central region 718 between the outer regions720. As shown, a pair of anchoring struts or tines 734 may be providedthat extend inwardly from the opposite outer regions 720 such that thestruts 734 are dispose adjacent one another. The tines 734 may be biasedto lie within the plane of the implant 710 or may be biased out of theplane, similar to other embodiments herein.

In addition, as shown, the tines 734 include pointed or sharpened tipson their free ends, which may facilitate driving or otherwise insertingthe tines 734 into tissue, e.g., with or without a preexisting incision.Alternatively, the tines 734 may include enlarged tips (not shown),similar to other embodiments herein, or other embodiments of anchoringstruts herein may include pointed or sharpened tips instead of enlargedtips. Similar to other embodiments herein, the implant 710 may beintroduced and implanted within an oropharyngeal region, e.g., such thatthe central region 718 extends across the posterior wall with the struts734 inserted into tissue adjacent the posterior wall, and the outerregions 720 providing an outward force on the lateral walls of theoropharyngeal region.

Turning to FIG. 17, another embodiment of an implant 410 is shown thatis generally similar to the apparatus 110, described above, e.g., havinga generally “bow-tie” shape, i.e., including a relatively narrow centralregion 418 between relatively wide outer regions 420. In addition, froma top view, the implant 410 may have a planar or curved shape, similarto the other embodiments herein.

Unlike the previous embodiments, the implant 410 includes two separatesupport components 412 that may be provided separately and coupledtogether, e.g., in situ, to create the final implant 410. For example,each component 412 may include an outer region 420 including outercurved segments 444, e.g., defining a portion of a circle or ellipse,and segments 446 connecting ends of the curved segments 444 to thecentral region 418. The central regions 418 a, 418 b may include matingconnectors, e.g., for coupling the components 412 together. For example,as shown, one central region 418 a may include a female receptacle andthe other central region 418 b may include a male fitting that may beinserted into the receptacle. The connectors may be secured relative toone another, for example, by one or more of an interference fit, matingdetents, magnets, and the like (not shown), e.g., within the receptacleand/or on the fitting or otherwise on the central regions 418.

During use, one of the components, e.g., component 412 a, may beintroduced into a target site, and the central region 418 a of thecomponent 412 a may be inserted through or behind the ligament ALL (notshown, see, e.g., 4A and 4B) or other tissue structure, e.g., until thecentral region 418 a is exposed on the other side. The other component412 b may then be introduced and the central region 418 b engaged withthe central region 418 a to create the implant 410. One advantage of themultiple component implant 410 is that one of the outer regions does notneed to be compressed to be inserted through or behind the ligament ALL,unlike the implant 110 shown in FIGS. 4A and 4B. Thus, the implant 410may be formed from spring material, e.g., elgiloy or stainless steel,that may have greater rigidity than the implant 110.

Other configurations of stents or implants may be provided that may besecured relative to the ligament ALL or other tissue structure. Forexample, a helical stent may be threaded through or behind the ligamentALL, which may wrap circumferentially around the oropharyngeal regionone or more times. FIGS. 18A-18F show additional alternative embodimentsof implants 1610A-1610F that may be placed at least partially through orbehind the ligament ALL, e.g., to secure and/or stabilize the implants.

In addition or alternatively, an implant or multiple component implantmay be screwed into the ligament in a “key ring” fashion. Rotating theimplant with the ligament at its center would allow the implant to screwin securely to the ligament. Some of the advantages of this type ofinsertion method are that no incisions may be required and the depth ofpenetration of the implant may be consistent for physicians andpatients. In the multiple component implant configuration, a foundationor first implant component may be screwed into the ligament region and,once in place, a second implant component may be attached to the firstimplant component, e.g., by an interference fit, mating detents,magnets, and the like, as described above.

It will be appreciated that elements or components shown with anyembodiment herein are exemplary for the specific embodiment and may beused on or in combination with other embodiments disclosed herein.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the scope ofthe appended claims.

1. An apparatus for implantation within an oropharyngeal region,comprising: an implant comprising a central region between first andsecond outer regions generally defining a plane in a substantially flatconfiguration, the outer regions defining lobes surrounding respectiveopen interior spaces on either side of the central region, the outerregions displaceable out of the plane such that the implant defines acurved configuration; and a first pair of opposing tines on the implantincluding tips oriented towards one another adjacent the central regionin the substantially flat configuration, the tips being directed awayfrom one another when the implant is directed to the curvedconfiguration to define a space therebetween for receiving tissue whenthe implant is introduced into an oropharyngeal region, wherein theouter regions are biased towards the substantially flat configuration toapply a force to dilate tissue adjacent the oropharyngeal region whenthe implant is disposed within the oropharyngeal region and to directthe tines towards one another to engage tissue received within the spacebetween the tips.
 2. The apparatus of claim 1, wherein the tines extendfrom the outer regions towards one another.
 3. The apparatus of claim 1,wherein the outer regions define a major axis of the implanttherebetween and wherein the central region has a relatively narrowheight compared to the outer regions along a minor axis of the implantorthogonal to the major axis.
 4. The apparatus of claim 1, furthercomprising features on the central region for engaging a tool, thefeatures spaced apart from one another such that a bending force appliedto the features causes the implant to be directed to the curvedconfiguration, thereby opening the space between the tines.
 5. Theapparatus of claim 1, wherein the tips are sharpened or pointed tofacilitate insertion into tissue.
 6. The apparatus of claim 1, whereinthe implant further comprises a second pair of tines adjacent the firstpair of tines, the second pair of opposing tines including tips orientedtowards one another, the tips being directed away from one another whenthe implant is directed to the curved configuration to define a spacetherebetween for receiving tissue when the implant is introduced into anoropharyngeal region.
 7. A system for treating at least one of sleepapnea and snoring, comprising: a tool comprising an elongate shaftincluding a proximal end and a distal end sized for introduction into anoropharyngeal region; an implant comprising a central region betweenfirst and second outer regions, the implant having a substantially flatconfiguration defining a plane when the implant is in a relaxed stateand deployable in a curved configuration when the outer portions aredirected towards one another out of the plane, and one or more pairs oftines extending from the central region out of the plane, tips of thetines being spaced further apart from one another in the curvedconfiguration than in the substantially flat configuration; andcooperating features on the distal end of the tool and the implant forreleasably securing the implant to the tool distal end in the curvedconfiguration, the implant biased to return towards the substantiallyflat configuration when released from the tool distal end.
 8. The systemof claim 7, wherein the cooperating features comprise rings or struts onthe implant spaced apart from one another adjacent respective outerregions.
 9. The system of claim 8, wherein the cooperating featurescomprise one or more rods or hooks on the tool distal end directablethrough the rings to secure the implant relative to the tool distal end.10. The system of claim 8, wherein the cooperating features furthercomprise grasper elements on the tool distal end for engaging respectiverings on the implant, the grasper elements being actuatable from thetool proximal end for directing the rings between first and secondpositions, thereby directing the implant between the substantially flatand curved configurations.
 11. An apparatus for implantation within anoropharyngeal region adjacent a ligament, comprising: an implantcomprising a central region between first and second outer regions, theouter regions defining lobes surrounding respective open areas on eitherside of the central region and defining a substantially flatconfiguration in a relaxed state lying generally within a plane; theouter regions displaceable towards one another such that the implantdefines a generally “C” shaped curved configuration, the outer regionsbeing biased towards the substantially flat configuration to apply aforce to dilate tissue adjacent the oropharyngeal region when theimplant is disposed within the oropharyngeal region; and one or morepairs of tines extending transversely from the central region out of theplane in the relaxed state.
 12. The apparatus of claim 11, wherein theone or more pairs of tines extend transversely out of the plane suchthat tips of the tines are oriented towards one another in the relaxedstate.
 13. The apparatus of claim 12, wherein the tips are directed awayfrom one another when the implant is directed to the curvedconfiguration to define a space therebetween for receiving tissue whenthe implant is introduced into an oropharyngeal region, the tines biasedtowards one another to engage tissue received within the space betweenthe tips when the implant is released from the curved configuration. 14.The apparatus of claim 11, wherein the one or more pairs of tines extendtransversely out of the plane such that tips of the tines are orientedaway from one another in the relaxed state.
 15. The apparatus of claim11, wherein the one or more pairs of tines extend transversely out ofthe plane such that tips of the tines extend substantially parallel andoffset from the plane in the relaxed state.
 16. An apparatus forimplantation within an oropharyngeal region adjacent a ligament,comprising: an implant comprising a central region between first andsecond outer regions, the outer regions defining lobes and defining asubstantially flat configuration in a relaxed state lying generallywithin a plane, the outer regions biased towards the substantially flatconfiguration to apply a force to dilate tissue adjacent theoropharyngeal region when the implant is disposed within theoropharyngeal region; and one or more pairs of tines extendingtransversely from the central region out of the plane in the relaxedstate to define a transverse orientation, the tines resilientlydirectable to a delivery orientation wherein tips of the tines extendsubstantially perpendicular to the plane, the tines biased to returntowards the transverse orientation.
 17. The apparatus of claim 16,wherein the one or more pairs of tines extend transversely out of theplane such that tips of the tines are oriented towards one another inthe relaxed state.
 18. The apparatus of claim 16, wherein the one ormore pairs of tines extend transversely out of the plane such that tipsof the tines are oriented away from one another in the relaxed state.19. The apparatus of claim 16, wherein the tips of the tines areoriented diagonally relative to the plane in the relaxed state. 20-42.(canceled)
 43. A method for treating at least one of sleep apnea andsnoring, comprising: providing an implant comprising a central regionbetween first and second outer regions in a relaxed state, the implantcomprising one or more pairs of tines extending from the central regionsuch that tips of the tines are oriented towards one another in therelaxed state; directing the implant to a curved configuration whereintips of the tines are spaced apart from one another; introducing theimplant into an oropharyngeal region of a patient in the curvedconfiguration; directing the tips of the tines into tissue adjacent theposterior wall of the oropharyngeal region; and releasing the implantwithin the oropharyngeal region such that the outer regions resilientlyreturn towards the relaxed state apply a force to against the lateralwalls of the oropharyngeal region and to direct the tines towards oneanother to engage tissue received within the space between the tips.44-52. (canceled)